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The company should publicly commit to human rights in relation to product development and marketing, by adopting an official human rights policy statement recognising the right to the highest attainable standard of health. The company should endeavour to integrate human rights into its strategies, policies, programmes, projects, and activities.
The company should also have a publicly available global access plan for their Covid-19 product, based on human rights standards, with measurable targets and lines of accountability.
CellTrion has not published a global access plan for its product.
The company should constructively engage with international initiatives for the equitable distribution of vaccines and therapeutics, such as the Covid-19 Technology Access Pool (C-TAP) or the Medicines Patent Pool (MPP), and the ACT Accelerator (COVAX). The company should also publicly commit to not enforcing the exclusive rights of Covid-19 related patents, and enter into non-exclusive, transparent licensing agreements for its Covid-19 products with other companies.
Celltrion has not committed to C-TAP or the MPP, but was one of 18 generic companies that signed a pledge in November 2020 to work with the Medicines Patent Pool ‘to accelerate access to hundreds of millions of doses of new Covid-19 interventions for low- and middle-income countries’.
Celltrion has not committed to not enforcing the exclusive rights of Covid-19 related patents.
Celltrion has not signed an agreement with the ACT Accelerator.
Celltrion has not signed a licensing agreement yet, but has signed a pledge with the MPP which includes “working with MPP to negotiate licences for patented effective COVID-19 therapeutics, as they become available.” and “accelerating development and delivery timelines for new treatments with technology transfer support from MPP and originators, as needed.”
The company should engage in efforts to further equitable distribution of Covid-19 vaccines/therapeutics, by equitably distributing its supplies globally, devising fair pricing strategies, and making the active ingredient for its product available to other manufacturers. The company should also engage in full technology transfer to other manufacturers, including the necessary transfer of skills, legal components, knowledge and intellectual property. Where applicable, the company should agree to waive rights in regulatory test data, and refrain from enforcing TRIPS+ measures.
Celltrion has not made the active ingredient for its therapeutic available to other manufacturers so far. However, the MPP pledge states that “Previously, we have worked together by sourcing active pharmaceutical ingredients from each other and expanding distribution networks for finished formulations.” so we can hope that this means Celltrion will also apply this principle to Regdanvimab
Celltrion has not committed to full technology transfer yet, but its pledge with the MPP includes “working with MPP to negotiate licences for patented effective COVID-19 therapeutics, as they become available.” and “accelerating development and delivery timelines for new treatments with technology transfer support from MPP and originators, as needed.”